Method for treating metastatic prostate cancer

ABSTRACT

A method for treating benign prostatic hyperplasia (BPH), prostatitis, and/or prostate cancer, including the step of administering an isothiocyanate functional surfactant to a patient affected by benign prostatic hyperplasia, prostatitis, and/or prostate cancer. In a preferred embodiment, the protonated form of the isothiocyanate functional surfactant is represented by the following chemical structure:

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. application Ser. No.17/120,228, entitled “METHOD FOR TREATING METASTATIC PROSTATE CANCER,”filed on Dec. 13, 2020, which is a continuation of U.S. application Ser.No. 16/814,403, entitled “METHOD FOR TREATING BENIGN PROSTATICHYPERPLASIA (BPH), PROSTATITIS, AND PROSTATE CANCER,” filed Mar. 10,2020, now U.S. Pat. No. 10,869,855, which is a continuation of U.S.application Ser. No. 16/539,465, entitled “METHOD FOR TREATING BENIGNPROSTATIC HYPERPLASIA (BPH), PROSTATITIS, AND PROSTATE CANCER,” filedAug. 13, 2019, now U.S. Pat. No. 10,583,107, which is a continuation ofU.S. application Ser. No. 16/025,386, entitled “METHOD FOR TREATINGBENIGN PROSTATIC HYPERPLASIA (BPH), PROSTATITIS, AND PROSTATE CANCER,”filed Jul. 2, 2018, now U.S. Pat. No. 10,441,561, which is acontinuation-in-part of U.S. application Ser. No. 15/838,444, entitled“METHOD FOR TREATING BLADDER CANCER” filed Dec. 12, 2017, now U.S. Pat.No. 10,111,852, which is a continuation of U.S. application Ser. No.15/423,869, entitled “METHOD FOR TREATING BLADDER CANCER” filed Feb. 3,2017, now U.S. Pat. No. 9,839,621, which is a continuation-in-part ofU.S. application Ser. No. 14/867,626, entitled “METHOD FOR TREATING SKINCANCER,” filed Sep. 28, 2015, now U.S. Pat. No. 9,642,827, which is acontinuation of U.S. application Ser. No. 14/867,585, entitled “METHODFOR TREATING SKIN CANCER,” filed Sep. 28, 2015, now U.S. Pat. No.9,636,320, which is a continuation of U.S. application Ser. No.14/519,510, entitled “METHOD FOR TREATING SKIN CANCER,” filed Oct. 21,2014, now U.S. Pat. No. 9,504,667, which is a continuation of U.S.application Ser. No. 13/952,236, entitled “METHOD FOR TREATING SKINCANCER,” filed Jul. 26, 2013, now U.S. Pat. No. 8,865,772, which claimsthe benefit of U.S. Provisional Application Ser. No. 61/676,093,entitled “METHOD FOR TREATING SKIN CANCER,” filed Jul. 26, 2012. All ofthe above documents are hereby incorporated herein by reference in theirentirety, including all references cited therein.

BACKGROUND 1. Field of the Invention

The present invention relates in general to a method for treating benignprostatic hyperplasia (BPH), prostatitis, and prostate cancer, and, moreparticularly, to a method for treating prostatic diseases and conditionswith an isothiocyanate functional surfactant.

2. Background Art

A plurality of methods for treating benign prostatic hyperplasia,prostatitis, and prostate cancer have been known in the art for yearsand are the subject of a plurality of patents and/or publications,including, for example: U.S. Pat. No. 8,815,309 entitled “Methods ofTreating a Subject with Benign Prostate Hyperplasia,” U.S. Pat. No.8,039,511 entitled “Use of Isothiocyanates Compounds in TreatingProstatic Diseases and Skin Cancer,” U.S. Pat. No. 7,332,482 entitled“Method for Treating Benign Prostatic Hyperplasia,” U.S. Pat. No.6,599,540 entitled “Use of a Serenoa Repens Extract for the Productionof a Medicament to Treat Prostate Cancer,” U.S. Pat. No. 6,423,719entitled “Method for Treating Benign Prostate Hyperplasia,” U.S. Pat.No. 6,399,115 entitled “Method and Composition for the Treatment ofBenign Prostate Hypertrophy (BPH) and Prevention of Prostate Cancer,”U.S. Pat. No. 6,384,044 entitled “Method of Treating Cancer of theProstate,” U.S. Pat. No. 6,368,598 entitled “Drug Complex for Treatmentof Metastatic Prostate Cancer,” U.S. Pat. No. 6,187,811 entitled“Methods for Treating Benign Prostatic Hyperplasia Using Tocotrienols,”U.S. Pat. No. 6,177,430 entitled “Use of α₁-Adrenoreceptor Antagonistsin the Prevention and Treatment of Benign Prostatic Hyperplasia,” U.S.Pat. No. 5,948,750 entitled “Conjugates Useful in the Treatment ofProstate Cancer,” U.S. Pat. No. 5,795,882 entitled “Method of TreatingProstatic Diseases Using Delayed and/or Sustained Release Vitamin DFormulations,” U.S. Pat. No. 5,753,641 entitled “Method of Treatment forBenign Prostatic Hyperplasia,” U.S. Pat. No. 5,116,615 entitled “Methodfor Treating Benign Prostatic Hypertrophy,” U.S. Pat. No. 4,659,695entitled “Method of Treatment of Prostate Cancer,” U.S. Pat. No.4,596,797 entitled “Use of Aromatase-Inhibitors for Prophylaxis and/orTreatment of Benign Prostatic Hyperplasia,” United States PatentApplication Publication No. 2010/0204319 entitled “Treatment for BenignProstatic Hyperplasia,” and United States Patent Application PublicationNo. 2001/0025059 entitled “Composition and Method for TreatingNon-Bacterial Prostatitis” all of which are hereby incorporated hereinby reference in their entirety—including all references cited therein.

U.S. Pat. No. 8,815,309 appears to disclose methods for treating a malesubject with a prostate condition, for example, benign prostatehyperplasia. In certain embodiments, the invention provides methods oftreating a male subject with a prostate condition, which includeadministering a MetAP2 inhibitor at a dose that does not substantiallymodulate angiogenesis. One example of a MetAP2 inhibitor includesfumagillin, the chemical structure of which is provided below:

U.S. Pat. No. 8,039,511 appears to disclose a method for preventing andtreating prostatic diseases and skin cancer using naturally orartificially synthesized isothiocyanates compounds or the derivatives ormetabolites thereof. One example of an isothiocyanate includes benzylisothiocyanate, the chemical structure of which is provided below:

U.S. Pat. No. 7,332,482 appears to disclose the use of1-alpha-fluoro-25-hydroxy-16,23E-diene-26,27-bishomo-20-epi-cholecalciferol,or a pharmaceutically acceptable salt or ester thereof, for themanufacture of a medicament for the prevention and/or treatment ofbenign prostatic hyperplasia and associated symptoms.

U.S. Pat. No. 6,599,540 appears to disclose the use of a lipido-sterolicSerenoa repens extract for the production of a medicament which isadministered in an isolated manner or in an associated manner, in asimultaneous, separated or staggered manner, with prostatectomy,radiotherapy and/or hormonotherapy in order to prevent and/or treatprostate cancer.

U.S. Pat. No. 6,423,719 appears to disclose a method of treating and/orpreventing renal dysfunction in a patient, such as renal colic orcontrast nephropathy by administering to a patient dyphylline, in asustained release oral dosage form, the chemical structure of which isprovided below:

U.S. Pat. No. 6,399,115 appears to disclose compositions comprisinglycopene, Serenoa repens, Pygeum africanum, andUrtica dioica. Thecompositions are preferably formulated with an alcohol extract of thedried, cut plant parts. Methods of using such compositions for treatingvarious conditions and diseases, including benign prostatic hypertrophyand prostate cancer are also provided.

U.S. Pat. No. 6,384,044 appears to disclose the administration, to thepatient, by a pharmacologically effective mode of an essentially pureopiate receptor antagonist, typified by Naltrexone and Naloxone,exerting substantially higher blocking action for Mu opiate receptorsites than against Delta opiate receptor sites at a low doseconcentration which produces therapeutic results corresponding to thoseobtained by the administration of Naltrexone at a low dosage level inthe range of 1.0 mg. to 10 mg. per day and at which Delta receptorblocking activity is at most small and Mu receptor blocking activity issubstantial. Naltrexone, the structure of which is provided below, issuitable for oral administration and is preferred:

U.S. Pat. No. 6,368,598 appears to disclose a drug complex for deliveryof a drug or other agent to a target cell, comprising a targetingcarrier molecule which is selectively distributed to a specific celltype or tissue containing the specific cell type; a linker which isacted upon by a molecule which is present at an effective concentrationin the environs of the specific cell type; and a drug or an agent to bedelivered to the specific cell type. In particular, a drug complex fordelivering a cytotoxic drug to prostate cancer cells, comprising atargeting carrier molecule which is selectively delivered to prostatetissue, bone or both; a peptide which is a substrate for prostatespecific antigen; and a cytotoxic drug which is toxic to androgenindependent prostate cancer cells.

U.S. Pat. No. 6,187,811 appears to disclose the treatment of benignprostatic hyperplasia using tocotrienols, such as P₁₈ tocotrienol andP₂₅ tocotrienol.

U.S. Pat. No. 6,177,430 appears to disclose a method for reducing theextent of or preventing further hyperplasia in BPH in a mammal whichcomprises administering to the mammal an effective amount of a drugcomprising an α₁-adrenoreceptor antagonist or pharmaceuticallyacceptable acid addition salt thereof. One example includes doxazocinand derivatives thereof, the chemical structure of which is providedbelow:

U.S. Pat. No. 5,948,750 appears to disclose chemical conjugates whichcomprise oligopeptides, having amino acid sequences that are selectivelyproteolytically cleaved by free prostate specific antigen (PSA). Suchconjugates are disclosed as useful in the treatment of prostatic cancerand benign prostatic hypertrophy.

U.S. Pat. No. 5,795,882 appears to disclose a method of treatingprostatic conditions such as prostate cancer and hyperplasia byadministering 1α-hydroxyprevitamin D or activated vitamin D or acombination thereof in a sustained release form or a delayed andsustained release formulation. Both the sustained release form and thedelayed, sustained release form deliver increased active vitamin D bloodlevels without significant risk of hypercalcemia associated with otheroral dosing of vitamin D forms, to provide a beneficial effect todiseased prostate tissue.

U.S. Pat. No. 5,753,641 appears to disclose a treatment for men withbenign prostatic hyperplasia, involving combination therapy of a5α-reductase inhibitor, e.g., a 17β-substituted 4-azasteroid, a17β-substituted non-azasteroid,17β-acyl-3-carboxy-androst-3,5-diene,benzoylaminophenoxybutanoic acidderivative, fused benz(thio)amide or cinnamoylamide derivative, aromatic1,2-diethers or thioethers, aromatic ortho acylaminophenoxy alkanoicacids, ortho thioalkylacylaminophenoxy alkanoic acids, pharmaceuticallyacceptable salts and esters thereof, and particularly finasteride, incombination with an α₁-adrenergic receptor blocker, i.e., terazosin.

U.S. Pat. No. 5,116,615 appears to disclose a composition and method fortreating benign prostatic hypertropy in mammals so as to cause thedissolution and regression of hypertrophied prostatic tissue and therebyprovide relief from the obstructive symptoms associated with thedisease. The present composition preferably comprises a sterilepyrogen-free solution of the hydrolytic enzymes collagenase andhyaluronidase, a nonionic surfactant, and an antibiotic; all provided,in a pharmaceutically acceptable, buffered, isotonic, aqueous carrier.

U.S. Pat. No. 4,659,695 appears to disclose a method of treatment ofprostate cancer in susceptible male animals including humans whosetesticular hormonal secretions are blocked by surgical or chemicalmeans, e.g., by use of an LH-RH agonist, e.g., [D-Trp⁶,des-Gly-NH_(2 hu 10)]LH-RH ethylamide which comprises administering anantiandrogen, e.g., flutamide in association with at least one inhibitorof sex steroid biosynthesis, e.g., aminoglutethimide and/orketoconazole.

U.S. Pat. No. 4,596,797 appears to disclose aromatase-inhibitors thatare used in a method of prophylaxis and/or treatment by therapy ofprostatic hyperplasia. A particularly preferred aromatase-inhibitor is,for example, testolactone, the chemical structure of which is providedbelow:

United States Patent Application Publication No. 2010/0204319 appears todisclose a method and composition for the treatment for bladder outletobstruction, particularly benign prostatic hyperplasia, which includesadministering to the mammal a therapeutically effective amount of asynergistic combination of Capsicum plants and aqueous extract fromcruciferous vegetables.

United States Patent Application Publication No. 2001/0025059 appears todisclose a composition and a method for treatment of prostate relateddysfunction and, particularly, non-bacterial prostatitis and, even moreparticularly, non-bacterial chronic prostatitis. The compositionprimarily relies upon the use of a bioflavonoid and, particularly, thatbioflavonoid known as quercetin, the chemical structure of which isprovided below:

While the above-identified medical treatments, as disclosed hereinabove,appear to provide at least some benefit to patients with benignprostatic hyperplasia, prostatitis, and/or prostate cancer, suchtreatments remain non-desirous and/or problematic inasmuch as, amongother things, none of the above-identified treatments provide sufficientresults from the debilitating effects of benign prostatic hyperplasia,prostatitis, and/or prostate cancer without material drawbacks and/orcompromises. As such, there remains a genuine demand for non-invasiveand/or substantially non-invasive medical treatments that are effectiveand that remedy the detriments and/or complications associated with bothconventional as well as the above-identified remedies.

It is therefore an object of the present invention to provide new,useful, and nonobvious methods for treating prostatic hyperplasia,prostatitis, and/or prostate cancer.

These and other objects of the present invention will become apparent inlight of the present specification, claims, and drawings.

SUMMARY

The present invention is directed to a method for treating benignprostatic hyperplasia (BPH), prostatitis, and/or prostate cancer,comprising the step of: administering an isothiocyanate functionalsurfactant to a patient affected by benign prostatic hyperplasia,prostatitis, and/or prostate cancer.

In a preferred embodiment of the present invention, the isothiocyanatefunctional surfactant comprises at least one isothiocyanate functionalgroup associated with an aliphatic and/or aromatic carbon atom of theisothiocyanate functional surfactant.

In another preferred embodiment of the present invention, theisothiocyanate functional surfactant comprises a lysine derivative,wherein the lysine derivative comprises an α-nitrogen and a ϵ-nitrogen,and wherein an alkyl and/or alkanoyl substituent comprising at leastapproximately 8 carbon atoms is associated with the α-nitrogen, andfurther wherein at least one isothiocyanate functional group isassociated with the ϵ-nitrogen.

In yet another preferred embodiment of the present invention, theisothiocyanate functional surfactant is represented by the followingchemical structure:

wherein the protonated form of the surfactant comprises a non-polarmoiety (NP) and a polar moiety (P), and wherein at least oneisothiocyanate functional group (NCS) is associated with the polarand/or non-polar moiety.

In another aspect of the present invention, the protonated form of theisothiocyanate functional surfactant is represented by the followingchemical structure:

wherein R₁ comprises an alkyl, cycloalkyl, polycycloalkyl,heterocycloalkyl, aryl, alkaryl, aralkyl, alkoxy, alkanoyl, aroyl,alkenyl, alkynyl and/or cyano group containing approximately 1 toapproximately 25 carbon atom(s), wherein the carbon atom(s) may be alinking group to, or part of, a halogen, a N, O, and/or S containingmoiety, and/or one or more functional groups comprising alcohols,esters, ammonium salts, phosphonium salts, and combinations thereof; alinkage to a dimer; a linkage to an oligomer; and/or a linkage to apolymer; wherein R₂ comprises NCS; and wherein R₃-R₅ are the same ordifferent and comprise H; OH; an alkyl, cycloalkyl, polycycloalkyl,heterocycloalkyl, aryl, alkaryl, aralkyl, alkoxy, alkanoyl, aroyl,alkenyl, alkynyl and/or cyano group containing approximately 1 toapproximately 25 carbon atom(s), wherein the carbon atom(s) may be alinking group to, or part of, a halogen, a N, O, and/or S containingmoiety, and/or one or more functional groups comprising alcohols,esters, ammonium salts, phosphonium salts, and combinations thereof; alinkage to a dimer; a linkage to an oligomer; and/or a linkage to apolymer with the proviso that at least one of R₃-R₅ comprise an alkyl,cycloalkyl, polycycloalkyl, heterocycloalkyl, aryl, alkaryl, aralkyl,alkoxy, alkanoyl, aroyl, alkenyl, alkynyl and/or cyano group containingapproximately 8 to approximately 25 carbon atom(s).

In a preferred embodiment of the present invention, the protonated formof the isothiocyanate functional surfactant is represented by thefollowing chemical structure:

wherein R₁ is selected from the group consisting of an alkyl groupcontaining 1 to 25 carbon atom(s); wherein R₂ is selected from the groupconsisting of NCS; and wherein R₃-R₅ are each independently selectedfrom the group consisting of H; OH; and an alkyl, and alkanoyl groupcontaining 1 to 25 carbon atom(s) with the proviso that at least one ofR₃-R₅ is selected from the group consisting of an alkyl, and alkanoyl,group containing 8 to 25 carbon atoms.

In another preferred embodiment of the present invention, the protonatedform of the isothiocyanate functional surfactant is represented by thefollowing chemical structure:

wherein X comprises an integer ranging from approximately 1 toapproximately 25, and wherein Y comprises an integer ranging fromapproximately 6 to approximately 25.

In yet another preferred embodiment of the present invention, theprotonated form of the isothiocyanate functional surfactant isrepresented by the following chemical structure:

In another aspect of the present invention, the protonated form of theisothiocyanate functional surfactant is represented by at least one ofthe following chemical structures:

In a preferred embodiment of the present invention, the isothiocyanatefunctional surfactant is represented by the following chemicalstructure:

wherein R₁ comprises an alkyl, cycloalkyl, polycycloalkyl,heterocycloalkyl, aryl, alkaryl, aralkyl, alkoxy, alkanoyl, aroyl,alkenyl, alkynyl and/or cyano group containing approximately 1 toapproximately 25 carbon atom(s), wherein the carbon atom(s) may be alinking group to, or part of, a halogen, a N, O, and/or S containingmoiety, and/or one or more functional groups comprising alcohols,esters, ammonium salts, phosphonium salts, and combinations thereof; alinkage to a dimer; a linkage to an oligomer; and/or a linkage to apolymer; wherein R₂ comprises NCS; wherein R₃-R₅ are the same ordifferent and comprise H; OH; an alkyl, cycloalkyl, polycycloalkyl,heterocycloalkyl, aryl, alkaryl, aralkyl, alkoxy, alkanoyl, aroyl,alkenyl, alkynyl and/or cyano group containing approximately 1 toapproximately 25 carbon atom(s), wherein the carbon atom(s) may be alinking group to, or part of, a halogen, a N, O, and/or S containingmoiety, and/or one or more functional groups comprising alcohols,esters, ammonium salts, phosphonium salts, and combinations thereof; alinkage to a dimer; a linkage to an oligomer; and/or a linkage to apolymer with the proviso that at least one of R₃-R₅ comprise an alkyl,cycloalkyl, polycycloalkyl, heterocycloalkyl, aryl, alkaryl, aralkyl,alkoxy, alkanoyl, aroyl, alkenyl, alkynyl and/or cyano group containingapproximately 8 to approximately 25 carbon atom(s), wherein X comprisesa counter cation such as, but not limited to, alkali metals, alkalineearth metals, transition metals, s-block metals, d-block metals, p-blockmetals, NZ₄ ⁺, wherein Z comprises, H, R₆, OR₆, and wherein R₆ comprisesan alkyl, cycloalkyl, polycycloalkyl, heterocycloalkyl, aryl, alkaryl,aralkyl, alkoxy, alkanoyl, aroyl, alkenyl, alkynyl and/or cyano groupcontaining approximately 1 to approximately 25 carbon atom(s), whereinthe carbon atom(s) may be a linking group to, or part of, a halogen, aN, O, and/or S containing moiety, and/or one or more functional groupscomprising alcohols, esters, ammonium salts, phosphonium salts, andcombinations thereof; a linkage to a dimer; a linkage to an oligomer;and/or a linkage to a polymer.

In another preferred embodiment of the present invention, theisothiocyanate functional surfactant is represented by the followingchemical structure:

wherein R₁ is selected from the group consisting of an alkyl groupcontaining 1 to 25 carbon atom(s); wherein R₂ is selected from the groupconsisting of NCS; and wherein R₃-R₅ are each independently selectedfrom the group consisting of H; OH; and an alkyl, and alkanoyl groupcontaining 1 to 25 carbon atom(s) with the proviso that at least one ofR₃-R₅ is selected from the group consisting of an alkyl, and alkanoyl,group containing 8 to 25 carbon atoms; and wherein X comprises a countercation.

In yet another preferred embodiment of the present invention, theisothiocyanate functional surfactant is administered to the patient atleast one of orally, intravenously, intramuscularly, intrathecally,cutaneously, subcutaneously, transdermally, sublingually, buccally,rectally, and nasally.

In a preferred embodiment of the present invention, the amount ofisothiocyanate functional surfactant topically administered to thepatient ranges from approximately 0.5 nmol/cm2 to approximately 10μmol/cm2.

In another preferred embodiment of the present invention, theisothiocyanate functional surfactant is a topical preparation selectedfrom the group consisting of ointment, cream, emulsion, lotion and gel.

In yet another preferred embodiment of the present invention, theisothiocyanate functional surfactant further comprises one or morepharmaceutical, biological or molecular biological active agents.

DETAILED DESCRIPTION

While this invention is susceptible of embodiment in many differentforms, there is shown in the drawings and/or described herein in detailseveral specific embodiments with the understanding that the presentdisclosure is to be considered as an exemplification of the principlesof the invention and is not intended to limit the invention to theembodiments illustrated.

In accordance with the present invention, methods for curing,eliminating, treating, and/or modulating benign prostatic hyperplasia,prostatitis, and/or prostate cancer are provided.

In one embodiment, the present invention is directed to a method fortreating benign prostatic hyperplasia, prostatitis, and/or prostatecancer by administering an isothiocyanate functional surfactant to apatient affected by benign prostatic hyperplasia, prostatitis, and/orprostate cancer. Preferably, the isothiocyanate functional surfactantcomprises one or more isothiocyanate functional groups associated withan aliphatic and/or aromatic carbon atom of the isothiocyanatefunctional surfactant. It will be understood that isothiocyanatefunctional surfactants, regardless of their ordinary meaning, aredefined herein as a surfactant having an isothiocyanate functional groupassociated therewith. It will be yet further understood that the term“associated” as used herein in chemical context, regardless of itsordinary meaning, is defined herein as attached, a covalent bond, apolar covalent bond, an ionic bond, a hydrogen bond, van der Waalsforces, electrostatic interaction, directly and/or indirectly linked,etcetera.

The term surfactant derives from contraction of the termssurface-active-agent and is defined herein as a molecule and/or group ofmolecules which are able to modify the interfacial properties of theliquids (aqueous and non-aqueous) in which they are present. Thesurfactant properties of these molecules reside in their amphiphiliccharacter which stems from the fact that each surfactant molecule hasboth a hydrophilic moiety and a hydrophobic (or lipophilic) moiety, andthat the extent of each of these moieties is balanced so that atconcentrations at or below the critical micelle concentration (i.e.,CMC) they generally concentrate at the air-liquid interface andmaterially decrease the interfacial tension. For example, sodium saltsof saturated carboxylic acids are extremely soluble in water up to C8length and are thus not true surfactants. They become less soluble inwater from C9 up to C18 length, the domain of effective surfactants forthis class of compounds. The carboxylic acids (fatty acids) can beeither saturated or unsaturated starting from C16 chain lengths.

Without being bound by any one particular theory, it is believed thatthe isothiocyanate functional surfactants disclosed herein facilitatetreatment of benign prostatic hyperplasia, prostatitis, and/or prostatecancer by eliminating, modulating, and/or reducing macrophage migrationinhibitory factor cytokine or its biological activity. It is alsobelieved that the isothiocyanate functional surfactants disclosed hereinfacilitate elevating phase II enzymes (e.g., HAD(P)H quinineoxidoreductase) which are believed to, among other things regulateinflammatory responses within the body, as well as detoxify carcinogensand/or activated carcinogens.

In accordance with the present invention, the isothiocyanate functionalsurfactants may be used as an administered leave-on/leave-in product inwhich one or more surfactants remain on/in the body and are notimmediately and/or ever removed from the body. Alternatively, theisothiocyanate functional surfactants of the present invention may beused in an administer and remove fashion. For either case, it ispreferred that the isothiocyanate functional surfactants be generallymild to human body (e.g., non-irritating or low-irritating). Inparticular, anionic N-alkanoyl surfactants derived from amino acids areespecially preferred because, while not completely predictable, theyhave a tendency to be mild. The methods of preparation detailed in thisinvention employ, but are not limited to, amino acids that possess atleast two amine functionalities, at least one of which is converted toan N-alkanoyl functionality, and at least one of which is converted intoisothiocyanate functionality. The amino acids include, but are notlimited to, the α-amino acids lysine, ornithine, 2,4-diaminobutanoicacid, 2,3-diaminopropionic acid, 2,7-diaminoheptanoic acid, and2,8-diaminooctanoic acid. Additionally, amino acids other than α-aminoacids may be employed, such as β-amino acids, etcetera. It will beunderstood that amino acid derived surfactants are preferred due totheir mild nature, but any one of a number of other surfactants arelikewise contemplated for use in accordance with the present invention.

Methods for preparing isothiocyanate functional surfactants and/or theirprecursors can involve, but are not limited to, conversion of an aminefunctionality to an isothiocyanate functionality. The methods ofconversion of amine functionalities to isothiocyanate functionalitiesinclude, but are not limited to: (1) reaction with carbon disulfide toyield an intermediate dithiocarbamate, followed by reaction withethylchloroformate or its functional equivalent such asbis(trichloromethyl)-carbonate, trichloromethyl chloroformate, orphosgene; (2) reaction with thiophosgene; (3) reaction with1,1′-thiocarbonyldiimidizole; (4) reaction with phenylthiochloroformate;(5) reaction with ammonium or alkali metal thiocyanate to prepare anintermediate thiourea followed by cleaving to the isothiocyanate viaheating; and (6) reaction with an isothiocyanato acyl halide[SCN—(CH₂)_(n)—CO—Cl]. The resulting isothiocyanate functionalsurfactant, depending on the method of preparation, can be isolated as apure material or as a mixture with other surfactants. The resultingisothiocyanate functional surfactant, depending on the method ofpreparation, can be isolated and used directly in nonionic form, anionicform, cationic form, zwitterionic (amphoteric) form, and/or in a neutralsurfactant-precursor form in combination with a base such as sodiumhydroxide or triethanol amine if the neutral surfactant-precursor formpossesses a protonated carboxylic acid group such that reaction(deprotonation) with the base converts the neutral surfactant-precursorform to an anionic surfactant, or in neutral surfactant-precursor formin combination with an acid if the neutral surfactant-precursor formpossess amine functionality such that reaction (protonation) with theacid converts the neutral surfactant-precursor form to a cationicsurfactant.

In accordance with the present invention the step of administeringcomprises, but is not limited to, systemic administration, localinjection, regional injection, applying, spraying, dripping, dabbing,rubbing, blotting, dipping, and any combination thereof.

In one preferred embodiment of the present invention, the isothiocyanatefunctional surfactant is removed from body and/or affected area after aperiod of time. Such a period comprises, but is not limited to, seconds(e.g., 1 second, 2 seconds, 5 seconds, 10 seconds, 15 seconds, 20seconds, 30 seconds, 45 seconds, and 60 seconds), minutes (e.g., 1minute, 2 minutes, 5 minutes, 10 minutes, 15 minutes, 20 minutes, 30minutes, 45 minutes, and 60 minutes), hours (e.g., 1 hour, 2 hours, 4hours, 5 hours, 8 hours, 10 hours, 15 hours, 24 hours, 36 hours, 48hours, and 60 hours), days (e.g., 1 day, 2 days, 3 days, 4 days, 5 days,6 days, 7 days, 10 days, 14 days, 21 days, 30 days), etcetera. It willbe understood that the step of removing preferably occurs via purging,rinsing, wiping, and/or extracting —just to name a few.

Depending upon the subject and/or the severity of the condition and/ordisease, multiple administrations may be necessary. As such, the stepsof administering and/or removing the isothiocyanate functionalsurfactant may be repeated one or a plurality of times.

The present invention is also directed to a method for treating benignprostatic hyperplasia, prostatitis, and/or prostate cancer comprisingthe step of associating (using any known medical technique) a lysinederivative to a patient, wherein the lysine derivative comprises anα-nitrogen and a 6-nitrogen. Preferably, an alkyl substituent comprisingat least approximately 8 carbon atoms is associated with the α-nitrogen.Preferably, at least one isothiocyanate functional group is associatedwith the ϵ-nitrogen.

The present invention is further directed to a method for treatingbenign prostatic hyperplasia, prostatitis, and/or prostate cancercomprising the step of: administering a surfactant to a patient, whereinthe surfactant is represented by the following chemical structure:

and wherein the surfactant comprises a non-polar moiety (NP) and a polarmoiety (P), and wherein at least one isothiocyanate functional group(NCS) is associated with the polar and/or non-polar moiety.

The present invention is yet further directed to a method for treatingbenign prostatic hyperplasia, prostatitis, and/or prostate cancercomprising the step of: administering a surfactant to a patient, whereinthe protonated form of the surfactant is represented by the followingchemical structure:

wherein R₁ comprises an alkyl, cycloalkyl, polycycloalkyl,heterocycloalkyl, aryl, alkaryl, aralkyl, alkoxy, alkanoyl, aroyl,alkenyl, alkynyl and/or cyano group containing approximately 1 toapproximately 25 carbon atom(s), wherein the carbon atom(s) may be alinking group to, or part of, a halogen, a N, O, and/or S containingmoiety, and/or one or more functional groups comprising alcohols,esters, ammonium salts, phosphonium salts, and combinations thereof; alinkage to a dimer; a linkage to an oligomer; and/or a linkage to apolymer; wherein R₂ comprises NCS; and wherein R₃-R₅ are the same ordifferent and comprise H; OH; an alkyl, cycloalkyl, polycycloalkyl,heterocycloalkyl, aryl, alkaryl, aralkyl, alkoxy, alkanoyl, aroyl,alkenyl, alkynyl and/or cyano group containing approximately 1 toapproximately 25 carbon atom(s), wherein the carbon atom(s) may be alinking group to, or part of, a halogen, a N, O, and/or S containingmoiety, and/or one or more functional groups comprising alcohols,esters, ammonium salts, phosphonium salts, and combinations thereof; alinkage to a dimer; a linkage to an oligomer; and/or a linkage to apolymer with the proviso that at least one of R₃-R₅ comprise an alkyl,cycloalkyl, polycycloalkyl, heterocycloalkyl, aryl, alkaryl, aralkyl,alkoxy, alkanoyl, aroyl, alkenyl, alkynyl and/or cyano group containingapproximately 8 to approximately 25 carbon atom(s).

In this embodiment, the surfactant is preferably represented by thefollowing chemical structure:

wherein X comprises an integer ranging from approximately 1 toapproximately 25, and wherein Y comprises an integer ranging fromapproximately 6 to approximately 25.

More preferably, the surfactant is represented by the following chemicalstructure:

In a preferred embodiment of the present invention, the protonated formof the isothiocyanate functional surfactant is represented by at leastone of the following chemical structures:

In another embodiment, the present invention is directed to a method fortreating benign prostatic hyperplasia, prostatitis, and/or prostatecancer comprising the step of: administering a surfactant to a patient,wherein the protonated form of the surfactant is represented by thefollowing chemical structure:

wherein R₁ comprises an alkyl, cycloalkyl, polycycloalkyl,heterocycloalkyl, aryl, alkaryl, aralkyl, alkoxy, alkanoyl, aroyl,alkenyl, alkynyl and/or cyano group containing approximately 1 toapproximately 25 carbon atom(s), wherein the carbon atom(s) may be alinking group to, or part of, a halogen, a N, O, and/or S containingmoiety, and/or one or more functional groups comprising alcohols,esters, ammonium salts, phosphonium salts, and combinations thereof; alinkage to a dimer; a linkage to an oligomer; and/or a linkage to apolymer; wherein R₂ comprises NCS; wherein R₃-R₅ are the same ordifferent and comprise H; OH; an alkyl, cycloalkyl, polycycloalkyl,heterocycloalkyl, aryl, alkaryl, aralkyl, alkoxy, alkanoyl, aroyl,alkenyl, alkynyl and/or cyano group containing approximately 1 toapproximately 25 carbon atom(s), wherein the carbon atom(s) may be alinking group to, or part of, a halogen, a N, O, and/or S containingmoiety, and/or one or more functional groups comprising alcohols,esters, ammonium salts, phosphonium salts, and combinations thereof; alinkage to a dimer; a linkage to an oligomer; and/or a linkage to apolymer with the proviso that at least one of R₃-R₅ comprise an alkyl,cycloalkyl, polycycloalkyl, heterocycloalkyl, aryl, alkaryl, aralkyl,alkoxy, alkanoyl, aroyl, alkenyl, alkynyl and/or cyano group containingapproximately 8 to approximately 25 carbon atom(s), wherein X comprisesa counter cation such as, but not limited to, alkali metals, alkalineearth metals, transition metals, s-block metals, d-block metals, p-blockmetals, NZ₄ ⁺, wherein Z comprises, H, R₆, and/or OR₆, and wherein R₆comprises an alkyl, cycloalkyl, polycycloalkyl, heterocycloalkyl, aryl,alkaryl, aralkyl, alkoxy, alkanoyl, aroyl, alkenyl, alkynyl and/or cyanogroup containing approximately 1 to approximately 25 carbon atom(s),wherein the carbon atom(s) may be a linking group to, or part of, ahalogen, a N, O, and/or S containing moiety, and/or one or morefunctional groups comprising alcohols, esters, ammonium salts,phosphonium salts, and combinations thereof; a linkage to a dimer; alinkage to an oligomer; and/or a linkage to a polymer.

In accordance with the present invention, the isothiocyanate functionalsurfactant may also be associated with one or more additionalsurfactants, wherein the additional surfactants are selected from atleast one of the group comprising a non-ionic surfactant, an anionicsurfactant, a cationic surfactant, a zwitterionic surfactant, andcombinations thereof.

Non-limiting examples of preferred anionic surfactants include taurates;isethionates; alkyl and alkyl ether sulfates; succinamates; alkylsulfonates, alkylaryl sulfonates; olefin sulfonates; alkoxy alkanesulfonates; sodium and potassium salts of fatty acids derived fromnatural plant or animal sources or synthetically prepared; sodium,potassium, ammonium, and alkylated ammonium salts of alkylated andacylated amino acids and peptides; alkylated sulfoacetates; alkylatedsulfosuccinates; acylglyceride sulfonates, alkoxyether sulfonates;phosphoric acid esters; phospholipids; and combinations thereof.Specific anionic surfactants contemplated for use include, but are by nomeans limited to, ammonium cocoyl isethionate, sodium cocoylisethionate, sodium lauroyl isethionate, sodium stearoyl isethionate,sodium lauroyl sarcosinate, sodium cocoyl sarcosinate, sodium laurylsarcosinate, disodium laureth sulfosuccinate, sodium laurylsulfoacetate, sodium cocoyl glutamate, TEA-cocoyl glutamate, TEA cocoylalaninate, sodium cocoyl taurate, potassium cetyl phosphate.

Non-limiting examples of preferred cationic surfactants includealkylated quaternary ammonium salts R₄NX; alkylated amino-amides(RCONH—(CH₂)_(n))NR₃X; alkylimidazolines; alkoxylated amines; andcombinations thereof. Specific examples of anionic surfactantscontemplated for use include, but are by no means limited to, cetylammonium chloride, cetyl ammonium bromide, lauryl ammonium chloride,lauryl ammonium bromide, stearyl ammonium chloride, stearyl ammoniumbromide, cetyl dimethyl ammonium chloride, cetyl dimethyl ammoniumbromide, lauryl dimethyl ammonium chloride, lauryl dimethyl ammoniumbromide, stearyl dimethyl ammonium chloride, stearyl dimethyl ammoniumbromide, cetyl trimethyl ammonium chloride, cetyl trimethyl ammoniumbromide, lauryl trimethyl ammonium chloride, lauryl trimethyl ammoniumbromide, stearyl trimethyl ammonium chloride, stearyl trimethyl ammoniumbromide, lauryl dimethyl ammonium chloride, stearyl dimethyl cetylditallow dimethyl ammonium chloride, dicetyl ammonium chloride, dilaurylammonium chloride, dilauryl ammonium bromide, distearyl ammoniumchloride, distearyl ammonium bromide, dicetyl methyl ammonium chloride,dicetyl methyl ammonium bromide, dilauryl methyl ammonium chloride,distearyl methyl ammonium chloride, distearyl methyl ammonium bromide,ditallow dimethyl ammonium chloride, ditallow dimethyl ammonium sulfate,di(hydrogenated tallow) dimethyl ammonium chloride, di(hydrogenatedtallow) dimethyl ammonium acetate, ditallow dipropyl ammonium phosphate,ditallow dimethyl ammonium nitrate, di(coconutalkyl)dimethyl ammoniumchloride, di(coconutalkyl)dimethyl ammonium bromide, tallow ammoniumchloride, coconut ammonium chloride, stearamidopropyl PG-imoniumchloride phosphate, stearamidopropyl ethyldimonium ethosulfate,stearimidopropyldimethyl (myristyl acetate) ammonium chloride,stearamidopropyl dimethyl cetearyl ammonium tosylate, stearamidopropyldimethyl ammonium chloride, stearamidopropyl dimethyl ammonium lactate,ditallowyl oxyethyl dimethyl ammonium chloride, behenamidopropyl PGdimonium chloride, dilauryl dimethyl ammonium chloride, distearlydimethyl ammonium chloride, dimyristyl dimethyl ammonium chloride,dipalmityl dimethyl ammonium chloride, distearyl dimethyl ammoniumchloride, stearamidoproyl PG-dimonium chloride phosphate,stearamidopropyl ethyldiammonium ethosulfate, stearamidopropyl dimethyl(myristyl acetate) ammonium chloride, stearimidopropyl dimethyl cetarylammonium tosylate, stearamido propyl dimethyl ammonium chloride,stearamidopropyl dimethyl ammonium lactate.

Non-limiting examples of preferred non-ionic surfactants includealcohols, alkanolamides, amine oxides, esters (including glycerides,ethoxylated glycerides, polyglyceryl esters, sorbitan esters,carbohydrate esters, ethoxylated carboxylic acids, phosphoric acidtriesters), ethers (including ethoxylated alcohols, alkyl glucosides,ethoxylated polypropylene oxide ethers, alkylated polyethylene oxides,alkylated polypropylene oxides, alkylated PEG/PPO copolymers), siliconecopolyols. Specific examples of non-ionic surfactants contemplated foruse include, but are by no means limited to, cetearyl alcohol,ceteareth-20, nonoxynol-9, C12-15 pareth-9, POE(4) lauryl ether,cocamide DEA, glycol distearate, glyceryl stearate, PEG-100 stearate,sorbitan stearate, PEG-8 laurate, polyglyceryl-10 trilaurate, laurylglucoside, octylphenoxy-polyethoxyethanol, PEG-4 laurate, polyglyceryldiisostearate, polysorbate-60, PEG-200 isostearyl palmitate, sorbitanmonooleate, polysorbate-80.

Non-limiting examples of preferred zwitterionic or amphotericsurfactants include betaines; sultaines; hydroxysultaines, amidobetaines, amidosulfo betaines; and combinations thereof. Specificexamples of amphoteric surfactants contemplated for use include, but areby no means limited to, cocoamidopropyl sultaine, cocoamidopropylhydroxyl sultaine, cocoamidopropylbetaine, coco dimethyl carboxymethylbetaine, lauryl dimethyl carboxymethyl betaine, lauryl dimethylalphacarboxyethyl betaine, cetyl dimethyl carboxymethyl betaine, cetyldimethyl betaine, lauryl (2-bishydroxy) carboxymethyl betaine, stearylbis-(2-hydroxyethyl) carboxymethyl betaine, oelyl dimethylgamma-carboxypropyl betaine, lauryl bis-(2-hydroxypropyl)alphacarboxymethyl betaine, coco dimethyl sulfopropyl betaine, stearyldimethyl sulfopropyl betaine, lauryl dimethyl sulfoethyl betaine, laurylbis(2-hydroxyethyl) sulfopropyl betaine, oleyl betaine, cocamidopropylbetaine.

In further accordance with the present invention, the isothiocyanatefunctional surfactant may optionally be incorporated into a formulationcomprising one or more solvents. Preferably, the solvent comprises ahydrocarbon and/or silicone oil that is generally non-hygroscopic and/orgenerally hydrophobic. Suitable examples, include, silicone basedsolvents and/or fluids, mineral oil, vegetable oils, squalene (i.e.,2,6,10,15,19,23-hexamethyltetracosane)—just to name a few.

The invention is further described by the following examples.

EXAMPLE I Preparation of a Mixture ofN_(α)-lauroyl-N_(ϵ)-isothiocyanato-L-Lysine withN_(α),N_(ϵ)-bis-lauroyl-L-lysine

A 1 liter beaker equipped with an overhead mechanical stainless steelpaddle stirrer was charged with 100 mL of 1 M NaOH (0.100 mol). Stirringwas begun and the beaker cooled to −5° C. to −10° C. using a salt/icebath. Next, 23.4 g (0.100 mol) of N_(ϵ)-benzylidene-L-lysine (preparedvia the method of Bezas, B and Zervas, L., JACS, 83, 1961, 719-722) wasadded. Immediately afterward and while keeping the solution cold, 140 mL(0.140 mol) of precooled (in a salt/ice bath) 1 M NaOH and 26.1 mL oflauroyl chloride was added in two equal portions over a period of 6minutes. The mixture was stirred for 10 more minutes at −5 to −10° C.,then the ice bath was removed and the reaction mixture allowed to stirfor another 1 hour while warming to room temperature. Next, the reactionmixture was cooled using a salt/ice bath and then sufficientconcentrated HCl was added to adjust the pH to 7.5-7.8. With the pH at7.8-7.8 and with continued cooling and stirring, 4.6 mL (60% ofstoichiometric, 0.068 mol) of thiophosgene was added drop-wise via anadditional funnel over the period of 1 hour. During this time,sufficient 1 M NaOH was added to maintain a pH range between 7.5-7.8.After the thiophosgene addition was complete, additional 1 M NaOH wasadded as necessary until the pH stabilized in 7.5-7.8 range. Next,sufficient 30% NaOH was added to adjust the pH to approximately 8.5.Next, 12 mL (0.051 mol) of lauroyl chloride was rapidly added, followedby sufficient 1 M NaOH to keep the pH in the range of 8.00-8.50. Next,sufficient concentrated HCl was added to adjust the pH to 1.5. Thereaction mixture was filtered via vacuum filtration, and the precipitatewashed with dilute HCl (pH=2). The product, a white moist solid, wasdried in vacuo while heating to 60° C. 45.19 g of white solid productwas recovered, a mixture of predominantlyN_(α)-lauroyl-N_(ϵ)-isothiocyanato-L-lysine andN_(α),N_(ϵ)-bis-lauroyl-L-lysine (determined via LC-MS analysis). Bothcompounds in this mixture can be simultaneously converted into anionic(carboxylate) surfactants via reaction with aqueous NaOH to yield aclear aqueous solution of the surfactants.

EXAMPLE II Preparation of PureN_(α)-lauroyl-N_(ϵ)-isothiocyanato-L-Lysine Step 1: Preparation ofN_(α)-lauroyl-N_(ϵ)-carbobenzoxy-L-Lysine

60.0 g of N_(ϵ)-cbz-L-Lysine (cbz is carbobenzoxy) purchased fromAtomole Scientific Company, LTD was added to a three-liter beaker alongwith 1200 mL of RO water and the mixture was stirred. Next, 39 mL of 30%aqueous NaOH was added, resulting in dissolution of theN_(ϵ)-cbz-L-Lysine. The resulting solution was cooled in an ice bath andthen 52.5 mL of lauroyl chloride was added. The ice bath was removed 30minutes later, and stirring continued for an additional six hours, atwhich time 18 mL of concentrated hydrochloric acid was added. Thereaction mixture was then filtered via vacuum filtration, the whitesolid product washed with 1 M aqueous HCl, and then the solid productwas dried in vacuo while heated to approximately 85° C. 96.5 g of drywhite solid product was obtained. The product can be further purified bydissolving it in methanol, filtering off any insoluble precipitate, andremoving the methanol in vacuo to recover a white solid product (mp99.5-103.0° C.)

Step 2: Preparation of N_(α)-lauroyl-N_(ϵ)-ammonium chloride-L-Lysine

10.0 g of N_(α)-lauroyl-N_(ϵ)-carbobenzoxy-L-Lysine was weighed into aone liter Erlenmeyer flask equipped with a magnetic stir bar. 150 mL ofconcentrated hydrochloric acid was added and the solution was stirredand heated in an oil bath to 104° C., then allowed to cool with the oilbath back to room temperature. The solution was then cooled to 9° C. forapproximately four hours, during which time a large mass of whiteprecipitate formed. The reaction mixture was filtered in vacuo andrinsed with a small amount of cold 1 M HCl. The white solid reactionproduct was then dried in vacuo while being heated to 78° C., yielding7.89 g of white solid product (mp 191-193° C.).

Step 3: Preparation of N_(α)-lauroyl-N_(ϵ)-isothiocyanato-L-Lysine

0.46 mL of thiophosgene was added to 30 mL of dichloromethane in a 125mL Erlenmeyer flask equipped with a magnetic stir bar. To this solutionwas drop wise added over 15 minutes a solution consisting of 2.00 gN_(α)-lauroyl-N_(ϵ)-ammonium chloride-L-Lysine, 10 mL RO water, and 2.7mL 20% aqueous NaOH. Stirring was continued for an additional 30minutes, after which sufficient concentrated hydrochloric acid was addedto lower the pH to 1 as indicated by testing with pHydrion paper. Thereaction solution was then transferred into a reparatory funnel and thebottom turbid dichloromethane layer was isolated and dried withanhydrous magnesium sulfate and gravity filtered. To the filtrate wasadded 50 mL of hexanes. The solution was then concentrated via removalof 34 mL of solvent via trap-to-trap distillation and then placed in a−19° C. freezer. A mass of white precipitate formed after a few hoursand was isolated via vacuum filtration and then dried in vacuo for 2hours. 1.130 g of a slightly off white solid powder product was obtained[mp 37.0-39.0° C.; IR (cm⁻¹), 3301sb, 2923s, 2852s, 2184m, 2099s, 1721s,1650s, 1531s, 1456m, 1416w, 1347m, 1216m, 1136w].

The oils and/or solvents employed hereinabove are provided for thepurposes of illustration, and are not to be construed as limiting theinvention in any way. As such, the oils may be liquid, solid, or gel,and may be synthetic or of natural origin and include but are notlimited to waxes, esters, lipids, fats, glycerides, cyclic silicones,linear silicones, crosslinked silicones, alkylsilicones, siliconecopolyols, alkylated silicone copolyols, and/or hydrocarbons, and/orethoxylated versions of all of these.

The foregoing description merely explains and illustrates the inventionand the invention is not limited thereto except insofar as the appendedclaims are so limited, as those skilled in the art who have thedisclosure before them will be able to make modifications withoutdeparting from the scope of the invention.

What is claimed is:
 1. A method of treating metastatic prostate cancercomprising the step of: administering a product to a patient havingmetastatic prostate cancer wherein the product comprises: anisothiocyanate functional surfactant; and at least one an additionalsurfactant chosen from the group comprising a non-ionic surfactant, ananionic surfactant, a cationic surfactant, a zwitterionic surfactant,and combinations thereof.
 2. The method of treating metastatic prostatecancer of claim 1, wherein the isothiocyanate functional surfactant isadministered to the patient at least one of orally, intravenously,intramuscularly, intrathecally, cutaneously, subcutaneously,transdermally, sublingually, buccally, rectally, and nasally.
 3. Themethod of treating metastatic prostate cancer of claim 1, wherein theproduct is administered by applying the product to skin and the methodtreating metastatic prostate cancer further comprising a step ofremoving the product from skin of the patient a period of time after theproduct is applied to the skin.
 4. The method of treating metastaticprostate cancer of claim 1, wherein the at least one an additionalsurfactant consists of at least one non-ionic surfactant and the atleast one non-ionic surfactant is chosen from a group consisting of:alcohols, alkanolamides, amine oxides, esters, ethers, siliconecopolyols, cetearyl alcohol, ceteareth-20, nonoxynol-9, C12-15 pareth-9,POE(4) lauryl ether, cocamide DEA, glycol distearate, glyceryl stearate,PEG-100 stearate, sorbitan stearate, PEG-8 laurate, polyglyceryl-10trilaurate, lauryl glucoside, octylphenoxy-polyethoxyethanol, PEG-4laurate, polyglyceryl diisostearate, polysorbate-60, PEG-200 isostearylpalmitate, sorbitan monooleate, polysorbate-80 and combinations thereof.5. The method of treating metastatic prostate cancer of claim 1, whereinthe at least one an additional surfactant consists of at least oneanionic surfactant and the at least one anionic surfactant is chosenfrom a group consisting of: taurates; isethionates; alkyl and alkylether sulfates; succinamates; alkyl sulfonates, alkylaryl sulfonates;olefin sulfonates; alkoxy alkane sulfonates; sodium and potassium saltsof fatty acids derived from natural plant or animal sources orsynthetically prepared; sodium, potassium, ammonium, and alkylatedammonium salts of alkylated and acylated amino acids and peptides;alkylated sulfoacetates; alkylated sulfosuccinates; acylglyceridesulfonates, alkoxyether sulfonates; phosphoric acid esters;phospholipids, ammonium cocoyl isethionate, sodium cocoyl isethionate,sodium lauroyl isethionate, sodium stearoyl isethionate, sodium lauroylsarcosinate, sodium cocoyl sarcosinate, sodium lauryl sarcosinate,disodium laureth sulfosuccinate, sodium lauryl sulfoacetate, sodiumcocoyl glutamate, TEA-cocoyl glutamate, TEA cocoyl alaninate, sodiumcocoyl taurate, potassium cetyl phosphate and combinations thereof. 6.The method of treating metastatic prostate cancer of claim 1, whereinthe at least one an additional surfactant consists of at least onecationic surfactant and wherein the cationic surfactant is chosen from agroup consisting of: alkylated quaternary ammonium salts R₄NX; alkylatedamino-amides (RCONH—(CH2)n)NR3X; alkylimidazolines; alkoxylated amines,cetyl ammonium chloride, cetyl ammonium bromide, lauryl ammoniumchloride, lauryl ammonium bromide, stearyl ammonium chloride, stearylammonium bromide, cetyl dimethyl ammonium chloride, cetyl dimethylammonium bromide, lauryl dimethyl ammonium chloride, lauryl dimethylammonium bromide, stearyl dimethyl ammonium chloride, stearyl dimethylammonium bromide, cetyl trimethyl ammonium chloride, cetyl trimethylammonium bromide, lauryl trimethyl ammonium chloride, lauryl trimethylammonium bromide, stearyl trimethyl ammonium chloride, stearyl trimethylammonium bromide, lauryl dimethyl ammonium chloride, stearyl dimethylcetyl ditallow dimethyl ammonium chloride, dicetyl ammonium chloride,dilauryl ammonium chloride, dilauryl ammonium bromide, distearylammonium chloride, distearyl ammonium bromide, dicetyl methyl ammoniumchloride, dicetyl methyl ammonium bromide, dilauryl methyl ammoniumchloride, distearyl methyl ammonium chloride, distearyl methyl ammoniumbromide, ditallow dimethyl ammonium chloride, ditallow dimethyl ammoniumsulfate, di(hydrogenated tallow) dimethyl ammonium chloride,di(hydrogenated tallow) dimethyl ammonium acetate, ditallow dipropylammonium phosphate, ditallow dimethyl ammonium nitrate,di(coconutalkyl)dimethyl ammonium chloride, di(coconutalkyl)dimethylammonium bromide, tallow ammonium chloride, coconut ammonium chloride,stearamidopropyl PG-imonium chloride phosphate, stearamidopropylethyldimonium ethosulfate, stearimidopropyldimethyl (myristyl acetate)ammonium chloride, stearamidopropyl dimethyl cetearyl ammonium tosylate,stearamidopropyl dimethyl ammonium chloride, stearamidopropyl dimethylammonium lactate, ditallowyl oxyethyl dimethyl ammonium chloride,behenamidopropyl PG dimonium chloride, dilauryl dimethyl ammoniumchloride, distearly dimethyl ammonium chloride, dimyristyl dimethylammonium chloride, dipalmityl dimethyl ammonium chloride, distearyldimethyl ammonium chloride, stearamidoproyl PG-dimonium chloridephosphate, stearamidopropyl ethyldiammonium ethosulfate,stearamidopropyl dimethyl (myristyl acetate) ammonium chloride,stearimidopropyl dimethyl cetaryl ammonium tosylate, stearamido propyldimethyl ammonium chloride, stearamidopropyl dimethyl ammonium lactateand combinations thereof.
 7. The method of treating metastatic prostatecancer of claim 1, wherein the at least one an additional surfactantconsists of at least one zwitterionic surfactant and wherein thezwitterionic surfactant is chosen from the group consisting of betaines;sultaines; hydroxysultaines, amido betaines, amidosulfo betaines,cocoamidopropyl sultaine, cocoamidopropyl hydroxyl sultaine,cocoamidopropylbetaine, coco dimethyl carboxymethyl betaine, lauryldimethyl carboxymethyl betaine, lauryl dimethyl alphacarboxyethylbetaine, cetyl dimethyl carboxymethyl betaine, cetyl dimethyl betaine,lauryl (2-bishydroxy) carboxymethyl betaine, stearylbis-(2-hydroxyethyl) carboxymethyl betaine, oelyl dimethylgamma-carboxypropyl betaine, lauryl bis-(2-hydroxypropyl)alphacarboxymethyl betaine, coco dimethyl sulfopropyl betaine, stearyldimethyl sulfopropyl betaine, lauryl dimethyl sulfoethyl betaine, laurylbis(2-hydroxyethyl) sulfopropyl betaine, oleyl betaine, cocamidopropylbetaine and combinations thereof.
 8. The method of treating metastaticprostate cancer of claim 1, wherein the patient is a mammal.
 9. Themethod of treating metastatic prostate cancer of claim 8, wherein themammal is a human.
 10. The method of treating metastatic prostate cancerof claim 1, wherein the product further comprises one or more solvents.11. The method of treating metastatic prostate cancer of claim 10,wherein the one or more solvents comprises a solvent chosen from thegroup consisting of silicone based solvents, silicon based fluids,mineral oil, vegetable oils, and squalene.
 12. The method treatingmetastatic prostate cancer of claim 1, wherein the product is a topicalpreparation selected from a group consisting of ointment, cream,emulsion, lotion and gel.
 13. A method of treating metastatic prostatecancer comprising the steps of: contact a product to a part of a humanaffected by metastatic prostate cancer wherein the product comprises afirst surfactant or pharmaceutically acceptable salt thereof and asecond surfactant to an area affected by metastatic prostate cancerwherein the first surfactant is represented by the following chemicalstructure:

wherein R₁ comprises an alkyl, cycloalkyl, polycycloalkyl,heterocycloalkyl, aryl, alkaryl, aralkyl, alkoxy, alkanoyl, aroyl,alkenyl, alkynyl and/or cyano group containing approximately 1 toapproximately 25 carbon atom(s), wherein the carbon atom(s) may be alinking group to, or part of, a halogen, a N, O, and/or S containingmoiety, and/or one or more functional groups comprising alcohols,esters, ammonium salts, phosphonium salts, and combinations thereof; alinkage to a dimer; a linkage to an oligomer; and/or a linkage to apolymer; wherein R₂ comprises NCS; wherein R₃-R₅ are the same ordifferent and comprise H; OH; an alkyl, cycloalkyl, polycycloalkyl,heterocycloalkyl, aryl, alkaryl, aralkyl, alkoxy, alkanoyl, aroyl,alkenyl, alkynyl and/or cyano group containing approximately 1 toapproximately 25 carbon atom(s), wherein the carbon atom(s) may be alinking group to, or part of, a halogen, a N, O, and/or S containingmoiety, and/or one or more functional groups comprising alcohols,esters, ammonium salts, phosphonium salts, and combinations thereof; alinkage to a dimer; a linkage to an oligomer; and/or a linkage to apolymer with the proviso that at least one of R₃-R₅ comprise an alkyl,cycloalkyl, polycycloalkyl, heterocycloalkyl, aryl, alkaryl, aralkyl,alkoxy, alkanoyl, aroyl, alkenyl, alkynyl and/or cyano group containingapproximately 8 to approximately 25 carbon atom(s), wherein X comprisesa counter cation such as, but not limited to, alkali metals, alkalineearth metals, transition metals, s-block metals, d-block metals, p-blockmetals, NZ₄ ⁺, wherein Z comprises, H, R₆, OR₆, and wherein R₆ comprisesan alkyl, cycloalkyl, polycycloalkyl, heterocycloalkyl, aryl, alkaryl,aralkyl, alkoxy, alkanoyl, aroyl, alkenyl, alkynyl and/or cyano groupcontaining approximately 1 to approximately 25 carbon atom(s), whereinthe carbon atom(s) may be a linking group to, or part of, a halogen, aN, O, and/or S containing moiety, and/or one or more functional groupscomprising alcohols, esters, ammonium salts, phosphonium salts, andcombinations thereof; a linkage to a dimer; a linkage to an oligomer;and/or a linkage to a polymer.
 14. The method of treating metastaticprostate cancer of claim 13, wherein the product further comprises oneor more solvents.
 15. The method of treating metastatic prostate cancerof claim 13, wherein the one or more solvents comprises a solvent chosenfrom the group consisting of silicone based solvents, silicon basedfluids, mineral oil, vegetable oils, and squalene; and wherein firstsurfactant elevates phase II enzymes.
 16. The method of treatingmetastatic prostate cancer of claim 15, wherein the product furthercomprises one or more solvents.
 17. The method of treating metastaticprostate cancer of claim 13, wherein first surfactant elevates phase IIenzymes.
 18. A method of treating metastatic prostate cancer comprisingthe steps of: applying a product containing a surfactant orpharmaceutically acceptable salt thereof to an area of a patientaffected by metastatic prostate cancer wherein the surfactant isrepresented by the following chemical structure:

wherein R₁ is selected from the group consisting of an alkyl groupcontaining 1 to 25 carbon atom(s); wherein R₂ is selected from the groupconsisting of NCS; and wherein R₃-R₅ are each independently selectedfrom the group consisting of H; OH; and an alkyl, and alkanoyl groupcontaining 1 to 25 carbon atom(s) with the proviso that at least one ofR₃-R₅ is selected from the group consisting of an alkyl, and alkanoyl,group containing 8 to 25 carbon atoms; and wherein X comprises a countercation.
 19. The method of treating metastatic prostate cancer of claim18, wherein the patient is a human and the surfactant orpharmaceutically acceptable salt thereof is in a protonated formrepresented by the following chemical structure:


20. The method of treating metastatic prostate cancer of claim 17further comprising a step of administering an additional surfactantchosen from the group comprising a non-ionic surfactant, an anionicsurfactant, a cationic surfactant, a zwitterionic surfactant, andcombinations thereof.